Indoor tanning is a “Class II world” now, and many leading figures in the industry say it’s nothing to worry about.
By now, everyone knows that the U.S. Food and Drug Administration has reclassified tanning equipment and sunlamps as “Class II medical devices.” On the whole, major manufacturers and distribution companies say that this is good for the indoor tanning industry, and ist Magazine and the Indoor Tanning Association agree that this does not constitute excessive governmental interference. (Teen-tanning bans and the Tan Tax are a completely different story!) As the industry leaders interviewed for this article will attest, indoor tanning in America started with equipment and sunlamps as Class II medical devices, so the reclassification is, on the whole, not considered a threat to anyone’s livelihood. For those of you who are getting involved in your industry on a political level, you won’t want to miss this group’s highly valuable insight on this important topic.
What it Means for Equipment Makers…
Tanning equipment and sunlamp manufacturers are the ones most affected by the reclassification. These two industry sectors are now required to submit a pre-market notification (also called “510(k)”) to the FDA – and obtain FDA clearance – prior to marketing new products. For products already in the market, manufacturers have 450 days from June 2, 2014 to submit the 510(k). They also have 450 days (beginning June 2) to re-label existing equipment with the new, FDA-approved warning label. While this might seem like a long, drawn-out process involving lots of tedious work, representatives from many companies say it’s not as arduous as it seems, and all are currently working to complete these processes on time.
Many people are resistant to change, simply because it means leaving the comfort and security of what they know for a journey into the unknown. The folks at Ultrasun USA, however, are embracing the changes that the FDA reclassification is presenting the company. According to General Manager Bradley Clampitt, once the manufacturer/importer completes the 510(k) filing process for its existing tanning systems, Team Ultrasun will be able to focus upon whatever else it must face in the future. Bradley added, “After all is said and done, everything associated with the 510(k) process will ultimately be a benefit to our company and the industry. As I understand it, most of the related device compliance will be handled at our headquarters in Germany with some involvement from us here in the U.S.” Bradley says he looks forward to learning more about this process in the coming months.
Thirty years of manufacturing and distribution experience gives Jerry Deveney, Four Seasons VP of Business Development, a unique perspective on the FDA’s reclassification. Coming from a time when equipment and lamps were considered Class II devices, Deveney is confident in saying, “Tanning systems, lamps and devices are not toys, and there needs to be an adequate level of regulation to ensure that such devices are manufactured according to FDA regulations and specifications regarding output, maximum exposure time, etc. At the same time, everyone must realize that there are thousands of Class II medical devices that people use every day. Many of the products marketed on television for reducing fine lines and wrinkles, hair growth, hair removal, etc. are all Class II medical devices.”
“This is not an industry killer,” said Greg Henson, President of Heartland Tanning, Inc. As a manufacturer of UV tanning equipment, Henson says Heartland currently complies with many of the requirements for Class II medical devices. As he explained, “We were testing our exposure times, timers and electrical components long before this happened because these are things that we should be doing as responsible manufacturers.” Henson credits his company’s compliance to years of experience working in indoor tanning when equipment was first considered a Class II device. “Because the ruling is still new, we have a few questions about how all of this is going to be implemented,” he added, “but I have a feeling it won’t be difficult to adjust.”
During the 1980s, equipment and sunlamps were Class II medical devices, so this is nothing new for responsible manufacturers such as JK-North America. The reclassification is actually beneficial for the tanning industry, according to Hans-Juergen Kreitz, JK-North America CEO, in that it clarifies the speculation that’s surrounded this debate over the past few years. It also further increases product safety and consumer protection, he says, adding, “The FDA took a very reasonable approach addressing the mostly over-exaggerated demands voiced by opponents of the tanning industry. The JK Group has already been fulfilling and even exceeding the requirements on manufacturing standards related to Class II medical devices.” Everyone at JK-North America will continue to cooperate with the FDA in compliance with the reclassification order.
Class II was the order of the day when Susan Miller got her start in indoor tanning. Now that the FDA has returned to this classification, Miller, President/CEO of PC TAN sees it as “business as usual.” Miller added, “Manufacturers have always tested their products because consumer safety is the No. 1 concern. The reclassification and the 510(k) process will formalize and standardize these procedures.” As a North American importer of uwe, Kbl and Sportarredo tanning systems, Miller plans to continue to work closely with these manufacturers on the 510(k) process for all their tanning units for this market. Susan also said, “The manufacturers are working together to make the implementation process smooth for ourselves as well as salons.”
… and Sunlamp Makers
Under the FDA’s reclassification, sunlamp companies are held to the same standards as the makers of UV tanning units. In most cases, the major sunlamp companies were anticipating the FDA’s reclassification, making this sector well prepared for any changes.
While Kevin Apgar wasn’t in the sun biz during its early days, his 13 years at Cosmedico Light, Inc. have made him familiar with what Class II means. According to him, Cosmedico has always held itself to higher manufacturing standards, adding, “Our facility is already FDA-approved and exceeds Class I manufacturing requirements. And since we make other products that are considered Class II medical devices, we’re very familiar with the 510(k) process and have no problem complying with it.” Team Cosmedico is busy preparing the required paperwork for the more than 300 sunlamp products in its line-up, and Kevin hopes the process will provide him the opportunity to deepen the company’s dialogue and cooperation with the FDA.
With three sunlamp brands that are compatible with more than 250 sunlamps in the market, the folks at Interlectric Corp. take the FDA reclassification very seriously. Said Marketing Director Robert Brown, “Since we’ve always maintained open lines of communication with the FDA on all sunlamp manufacturing issues, I’m sure that this is something we can handle. From my understanding, it actually might make our lives here easier from a paperwork standpoint because the new classification allows for bundling of compatible lamps in groups during the 510(k) process.” As always, Brown and everyone else at Interlectric plan to keep in contact with the FDA to ensure the company completes its 510(k) process accurately and on time.
With 36 years of industry experience, Gene Czako is one of the many tanning veterans who started when tanning products were Class II. Even so, it was a different kind of Class II in those days, says Gene, Sales Engineer for Light Sources, Inc. “Back then,” he added, “the 510(k) process was much simpler; but we should have no problems complying with the new process.” This will mean filing 510(k) paperwork for its thousands of existing sunlamp products, Gene explained, as well as for any new sunlamp innovation the company plans to create. While this might seem like a tedious task, Gene was happy that the FDA will allow sunlamp manufacturers to “bundle” or group together similar products, which will cut down on excess time and paperwork. He added, “All in all, the FDA was very fair with this reclassification and we’ll do everything we need to do to comply with it.”
Wolff System Technology Corp. is preparing for the changes brought on by the FDA’s reclassification, says the company’s President, Michael Stepp. Regarding the 510(k) process, he added, “All in all, this move to Class II is not going to be so difficult for our industry.” Going forward, Wolff’s new sunlamps will need to conform to the new FDA requirements for pre-market notification and registration before they can come to market, and Stepp says he doesn’t anticipate this being a problem, either. “To its credit,” Stepp added, “the FDA has made this chore much less costly than it could have been.”
What it Means for YOU!
With something as potentially industry-changing as an FDA reclassification, salon owners across the country must be wondering, “What does this mean for ME?” According to the FDA’s documents, salon owners will soon be required to display a new warning label on all tanning units in their stores. According to the FDA, the decal must be printed with letters ten millimeters tall, appear in a black box and read: “Attention: This sunlamp product should not be used by persons under the age of 18 years.” Overstreet explained that these warning labels are a series matter, adding, “It’s called a contraindication and it does not ban indoor tanning for people under 18. Even so, salon operators need to make sure the label is visible on all tanning units, and that parents of customers under 18 are aware of it.”
On behalf of salon owners, the Indoor Tanning Association continues to closely monitor the FDA reclassification. Long before the change was announced, the group had been preparing the industry for the possibility, and the ITA provided plenty of input on this issue during the FDA’s open comments period. Now, John Overstreet, ITA Executive Director, says the organization is willing to help salon owners comply with the FDA’s latest requirements. He explained, “Members of the Board of Directors have been discussing the possibility of having the ITA be the source for salon owners to get warning labels. This would make it easy to obtain them, and we can inform salon owners where the label needs to be placed on the units, since the FDA’s wording on this is very specific.”
While the ITA is still working out the details of producing warning labels, members of the organization also plan to meet with representatives from the FDA to discuss other aspects of the reclassification. “We’ll release more information about this issue as we learn more from the FDA,” Overstreet said. “Until then, salon owners should plan to receive their warning labels from our organization and member companies.”
IST wishes to thank everyone who contributed to this article. Further news and information regarding the FDA reclassification can be found at theita.com. ■
